NCT00135031

Brief Summary

The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome (IBS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

August 23, 2005

Last Update Submit

June 14, 2011

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable was the abdominal pain score

Secondary Outcomes (1)

  • Bloating/distension, sense of incomplete evacuation, straining, urgency, passage of gas, number of bowel movements, passage of mucus, a composite symptom score, subject's assessment of IBS symptom relief, and quality of life

Interventions

Bifidobacterium infantis 35624DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet Rome II criteria for the diagnosis of IBS
  • Refrain from using probiotic supplements during the trial

You may not qualify if:

  • Organic diseases, including inflammatory bowel disease, and significant systemic diseases
  • Subjects over 55 years of age that had not had a sigmoidoscopy or colonoscopy performed in the previous five years
  • Use of anti-psychotic medications within the prior three months
  • Had major psychiatric disorder (DSM-II-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse, within the past two years
  • Were pregnant or nursing
  • Had known lactose intolerance or immunodeficiency
  • Had undergone any abdominal surgery, with the exception of hernia repair or appendectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

The Orchard Medical Centre

Bristol, Bristol, BS15 2NJ, United Kingdom

Location

Yaxley Group Practice, The Health Centre

Peterborough, Cambridgeshire, PE7 3JL, United Kingdom

Location

The Staploe Medical Centre

Soham, Cambridgeshire, CB7 5JD, United Kingdom

Location

Wansford Surgery

Wansford, Cambridgeshire, PE8 6PL, United Kingdom

Location

Old School Surgery

Greenisland, County Antrim, BT38 8TP, United Kingdom

Location

Springhill Surgery

Bangor, County Down, BT19 1PP, United Kingdom

Location

Downpatrick Health Centre

Downpatrick, County Down, BT30 6HY, United Kingdom

Location

Little Common Surgery

Bexhill-on-Sea, East Sussex, TN39 5JB, United Kingdom

Location

Sea Road Surgery

Bexhill-on-Sea, East Sussex, TN40 1JJ, United Kingdom

Location

Valleyfield Health Centre

High Valleyfield, Fife, KY 12 8SJ, United Kingdom

Location

Stanwell Road Surgery

Ashford, Middlesex, TW18 1SL, United Kingdom

Location

Belmont Health Centre

Harrow, Middlesex, HA3 7LT, United Kingdom

Location

The Frome Medical Practice

Frome, Somerset, BA11 1EZ, United Kingdom

Location

The Burns Practice

Doncaster, South Yorkshire, DN1 2EG, United Kingdom

Location

The Burngreave Surgery

Sheffield, South Yorkshire, S3 9DA, United Kingdom

Location

The Medical Centre

East Horsley, Surrey, KT 24 6QT, United Kingdom

Location

The Penylan Surgery

Cardiff, Wales, CF23 5SY, United Kingdom

Location

Sherbourne Medical Centre

Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

Location

Hathaway Surgery

Chippenham, Wiltshire, SN15 1HP, United Kingdom

Location

Swindon Medical Research Centre, Abbeymeads Medical

Swindon, Wiltshire, SN25 4YZ, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Peter J. Whorwell, M.D.

    Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

January 1, 2004

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations

GB(20)